Engage Coaching for Latinos

• ClinicalTrials.gov Identifier: NCT04875065
• Recruitment Status: Recruiting
• First Posted: May 6, 2021
• Last Update Posted: November 3, 2021
• Sponsor: University of Rochester
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Caroline Silva, University of Rochester

Study Description

Brief Summary:

This study asks: "what behavioral strategies are needed to help socially disconnected Hispanic/Latino caregivers with significant barriers to increasing connectedness?" This study uses a mixed methods approach to adapt a brief behavioral intervention-Social Engage psychotherapy-for use with socially disconnected Hispanic/Latino caregivers. This study is a single-arm clinical trial of Social Engage psychotherapy. We propose to enroll 30 participants for up to 8 weekly individual Social Engage psychotherapy sessions, over up to 3 months. Subjects will be aged 50 and older, and be caregivers for a community-dwelling family member with ADRD, living with (or in close proximity to) the family member with dementia, experiencing elevated caregiving distress and social disconnectedness.

Condition or disease	Intervention/treatment	Phase
Social Isolation; Loneliness; Caregiver Burnout	Behavioral: Engage coaching	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos
• Actual Study Start Date: January 24, 2021
• Estimated Primary Completion Date: May 31, 2022
• Estimated Study Completion Date: May 31, 2022

Arms and Interventions

Arm

Intervention/treatment

Experimental: Engage Coaching; Engage Coaching helps caregivers bolster motivation for increasing connectedness, teaches problem solving skills, and provides behavioral practice with social engagement. Up to 8 brief sessions (typically 30 minutes) are provided weekly over no more than three months.

Behavioral: Engage coaching; Participants will complete up to 8 weekly individual Social Engage psychotherapy sessions. Participants will be allotted up to 3 months to complete all sessions, a time-frame that allows for two weeks without meeting to address life stressors such as illnesses that may pop up. All sessions are provided via phone or videocall (Zoom). The first and last session are longer - up to 60 minutes if needed. Middle sessions are shorter (20-45 minutes). Engage is a stepped care psychotherapy in that the simplest strategy is taught first-action planning (a derivative of problem solving therapy)-and "barrier strategies" are added only if needed. Action plans are designed to address loneliness and social isolation in the context of caregiving demands.

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline in Basic Psychological Need Satisfaction at Post Intervention [ Time Frame: Baseline and 6 months ]
   The Basic Psychological Need Satisfaction and Frustration Scales (BPNSFS) will be used. The BPNSFS consists of 24 items assessing both satisfaction and frustration in the need for competence, autonomy, and relatedness, as posited by Self-Determination Theory. We will report changes in the three BPNSFS subscales measuring satisfaction in: autonomy, relatedness and competence. Items are scored on a 1-5 Likert scale with each subscale score ranging from 4-20. Higher scores indicating greater satisfaction. Mean change in subscale scores (change = post intervention scores - baseline scores) will be reported.
2. Change from Baseline in Loneliness at Post Intervention [ Time Frame: Baseline and 6 months ]
   The UCLA Loneliness Scale Version 3 will be used to assess self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness). Mean change in total scores (change = post intervention scores - baseline scores) will be reported.

Secondary Outcome Measures :

1. Change from Baseline in Social Functioning at Post Intervention [ Time Frame: Baseline and 6 months ]
   Satisfaction with Social Roles and Activities (PROMIS) is a computerized adaptive test (CAT). It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate better outcomes (i.e., greater satisfaction with social role and activities). Mean change in T scores (change = post intervention scores - baseline scores) will be reported.
2. Change from Baseline in Quality of Life at Post Intervention [ Time Frame: Baseline and 6 months ]
   The WHOQOL-BREF is a 36-item measure of several domains (physical health, psychological health, social relationships, environment) of health related quality of life. Higher scores denote higher quality of life. Items are scored on a 1-5 Likert scale with each domain score ranging from 3-40. Mean change in domain scores (change = post intervention scores - baseline scores) will be reported.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age ≥ 40 yrs;
2. Hispanic/Latino
3. English or Spanish speaking;
4. Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
5. Endorse elevated caregiving distress as measured by a score of ≥ 11 on the 10-item Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain Index (MCSI);
6. Endorse clinically significant loneliness as measured by a score of ≥ 6 on the UCLA Loneliness Scale: Short Form.
7. Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.

Exclusion Criteria:

1. Primary language is not English or Spanish;
2. Recent or current psychosis;
3. Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment;
4. Hearing problems that preclude completion of the intervention.

Contacts and Locations

Contacts

Contact: Caroline Silva, PhD; 585-275-2392; caroline_silva@urmc.rochester.edu

Locations

United States, New York

University of Rochester Medical Center; Recruiting

Rochester, New York, United States, 14642

Contact: Caroline Silva, PhD 585-275-2392 caroline_silva@urmc.rochester.edu

Sponsors and Collaborators

University of Rochester

National Institute on Aging (NIA)

More Information

• Responsible Party: Caroline Silva, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT04875065
• Other Study ID Numbers: STUDY00006126; P30AG064103 ( U.S. NIH Grant/Contract )
• First Posted: May 6, 2021
• Last Update Posted: November 3, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Caregiver Burden; Stress, Psychological; Behavioral Symptoms